drugset / Trial / NCT04452136

Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

NCT04452136

Summary

This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-PSMA-11 Diagnostic / imaging agent 111 mbq Intravenous
Subject 68Ga-PSMA-11 Diagnostic / imaging agent 259 mbq Intravenous

Indications